Validation of a Simple and Cost-Effective Nucleic Acid Test for HIV Detection

Completed

Conditions studied: HIV, HIV Infections

In brief

Validate a simple and cost-effective Nucleic Acid Test for HIV Detection in order to develop a rapid, highly sensitive and specific, one-stage test for the diagnosis of HIV infection. Blood samples collected will be assayed using the BioHelix Corporation helicase-dependent amplification or the Cepheid Xpert HIV-1 Quant Assay. A false negative or false positive rate of \>1.0% would make this test unacceptable as a screening test for HIV viremia.

Key facts

Study ID

NCT01084954

Run by

George Washington University

People needed

153

Starts

2009-03-01

Expected to finish

2016-04-01

Last updated by the study team

2016-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current patient in the Medical Faculty Associates Infectious Diseases (ID) clinic with known HIV infection
• Suspected to be viremic at the time of their clinic visit based on history and/or current symptoms
• Able to provide informed consent
• 18 Years or older

You may not qualify if…

• Patient unable to provide informed consent.
• Pregnancy

Where it is running

• The George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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